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NCT03875950: PrIYA-SP

Standardized Patient Encounters to Improve PrEP Counseling for Adolescent Girls and Young Women in Kenya

Completed NA Results posted Last updated 12 October 2022
What this trial tests

NA trial testing Clinician training intervention in HIV/AIDS in 232 participants. Completed in 2 December 2021.

Timeline
2 March 2019
Primary endpoint
30 June 2021
2 December 2021

Quick facts

Lead sponsorUniversity of Washington
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment232
Start date2 March 2019
Primary completion30 June 2021
Estimated completion2 December 2021
Sites1 location across Kenya

Drugs / interventions tested

Conditions studied

Sponsor

University of Washington

Who can join

18 and older, any sex, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Quality of PrEP Counseling Provided by Health Care Workers Delivering PrEP to Adolescent Girls and Young Women for HIV Prevention in Kenya Primary · Unannounced standardized patient actor visits take approximately 15 minutes each, taking place over 3-4 months.

Quality is assessed as total score from a checklist provided by the SPs after each unannounced visit (n=71 SP visits in each arm) including domains of communication skills and adherence to national guidelines. Communication quality is assessed in an adapted version of the Bayer-Fetzer Kalamazoo Consensus Statement; scores range from 7-28 with higher scores indicating higher quality communication. Guideline adherence is assessed in a scoring system adapted from the Kenyan National AIDS \& STI Control Programme guidelines; scores range from 0-13 with higher scores indicating higher PrEP competen

Overall quality
GroupValue95% CI
Training Intervention73.6± 16.3
Standard of Care Control58.4± 16.7
Guideline adherence
GroupValue95% CI
Training Intervention57.2± 25.4
Standard of Care Control36.2± 26.9
Communication skills
GroupValue95% CI
Training Intervention90.0± 10.9
Standard of Care Control80.5± 11.4
Competency Score Measuring Quality of PrEP Counseling Provided by Health Care Workers During Clinical Training Intervention [Among Intervention Arm Only] Secondary · Standardized patient actor training interactions take approximately 15 minutes each and will occur during a two-day training intervention. Trainings will be conducted over a period of 2-3 months.

The secondary outcome is PrEP competency among HCWs in interactions with SPs during the clinical training intervention, assessed as sub-scores for interpersonal skills, communication quality, and guideline adherence. Interpersonal skills are assessed using the Interpersonal skills (IPS) assessment tool (Van Zanten 2007); scores range from 1-16 with higher scores indicating better interpersonal skills. Communication quality is assessed in an adapted version of the Bayer-Fetzer Kalamazoo Consensus Statement; scores range from 7-28 with higher scores indicating higher quality communication. Guide

Overall quality (sum of adherence and communication)
GroupValue95% CI
Training Intervention83.1± 10.1
Guideline adherence
GroupValue95% CI
Training Intervention66.1± 20.7
Communication skills
GroupValue95% CI
Training Intervention96.2± 8.1
Interpersonal skills
GroupValue95% CI
Training Intervention86.9± 8.7

Sponsor's own description

The goal of this study is to facilitate uptake of and adherence to HIV pre-exposure prophylaxis (PrEP) among adolescent girls and young women (AGYW) in Kenya. The investigators will conduct a cluster randomized controlled trial at 24 health facilities in Kisumu, Kenya of a clinical training intervention using standardized patient actors. The hypothesis is that the training will improve quality of PrEP service delivery, defined as adherence to national guidelines and non-judgmental communication.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Defining gaps in pre-exposure prophylaxis delivery for pregnant and post-partum women in high-burden settings using an implementation science framework.
    Pintye J, Davey DLJ, Wagner AD, John-Stewart G, et al · · 2020 · cited 64× · PMID 32763221 · DOI 10.1016/s2352-3018(20)30102-8
  2. Standardised patient encounters to improve quality of counselling for pre-exposure prophylaxis (PrEP) in adolescent girls and young women (AGYW) in Kenya: study protocol of a cluster randomised controlled trial.
    Larsen A, Wilson KS, Kinuthia J, John-Stewart G, et al · · 2020 · cited 16× · PMID 32565464 · DOI 10.1136/bmjopen-2019-035689
  3. Patient actor training improves preexposure prophylaxis delivery for adolescent girls and young women in Kenya: a cluster randomized trial.
    Kohler P, Larsen A, Abuna F, Owiti G, et al · · 2024 · cited 2× · PMID 38857513 · DOI 10.1097/qad.0000000000003943

Verify or expand the search:

Other trials of Clinician training intervention

Trials testing the same drug.

Other recruiting trials for HIV/AIDS

Currently open trials in the same condition.

Other University of Washington trials

Trials by the same sponsor.

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Data sources for this page

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